Definition: To Protect An Endoscope From Contamination By Providing A Barrier Between The Body And The Endoscope.
| Device Type ID | 2069 |
| Device Name | Endoscopic Contamination Prevention Sheath |
| Physical State | Sheath |
| Technical Method | Placed Over Endoscope Before Insertion Into The Body |
| Target Area | Endoscope |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ODB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2069 |
| Device | Endoscopic Contamination Prevention Sheath |
| Product Code | ODB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Material Separation | 5 |
| Total Device Problems | 5 |